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510(k) K780277

Device
INFLUENZA HI PRESERUM A/TEXAS
Applicant
FLOW LABORATORIES, INC.
510(k) number
K780277
Product code
GNS  
Decision
Substantially Equivalent (SESE)
Decision date
1978-02-28
Date received
1978-02-17
Regulation
866.3330
Classification name
Antisera, Hai, Influenza Virus A, B, C
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GNS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K780696GOAT ANTIINFLUENZA ANTISERA AUSSRNortheast Biomedical Labs., Inc.1978-05-03
K780697GOAT ANTI-INFLUENZA ANTISERA ATEXASNortheast Biomedical Labs., Inc.1978-05-03
K780273INFLUENZA HI PRESERUMFlow Laboratories, Inc.1978-02-28
K780274INFLUENZA HI ANTISERUMFlow Laboratories, Inc.1978-02-28
K780276INFLUENZA HI ANTISERUM A/TEXASFlow Laboratories, Inc.1978-02-28
K780004GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.1978-01-20
K780005GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.1978-01-20
K780006GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.1978-01-20

Legacy Summary#

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FDA Review#

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